The candidate is responsible to support equipment qualification, system qualification and cleaning validation. In this role, the engineer must ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements.
Responsibilities:
- Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
- Take lead and review project design documents (P&IDs, PFDs, URS etc.)
- Define user requirements and create SOPs or documentation related to the validation activities
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
- Participate in site Validation Maintenance Program.
- Write execution related deviations and change requests
- Support change implementation on site.
- Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed
- Perform validation documentation and/ or support validation documentation in accordance to the division procedures
- Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager
- Ensure validation execution meets compliance, validation standards and cGMP requirements
- Any other task as assigned by Supervisor/Manager
About You:
- Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry
- Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)
- In-depth knowledge on cGMP, GDP and ASTM E2500
- Proactive and self-motivated
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)
- Effective Project Management, leadership, communication and interpersonal skills
To start mid Jul 2024 for 06 months
Contract extension option depending on performance and business needs
